Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00814723

Enrollment

Registered

2008-12-25

Start date

2005-09-30

Completion date

2007-09-30

Last updated

2008-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Brief summary

Patients with coronary heart disease (CHD) or CHD equivalent (e. g. diabetes mellitus) often have abnormalities in lipids (hypercholesterolemia). Besides, hypercholesterolemia is an evident risk factor for atherosclerosis. Hitherto, there are only few studies of patients with primary hypercholesterolemia where the combination therapy with statins (HMG-Co-reductase inhibitors) and ezetimib was investigated. This combination therapy should be more effective in reducing low density lipoprotein cholesterol (LDL-C) and total cholesterol levels compared to monotherapy.

Detailed description

Ezetimibe, a cholesterol-absorption inhibitor, significantly lowers low-density lipoprotein cholesterol (LDL-C) when administered in addition to statin treatment. The effect of ezetimibe on the incidence and progression of vascular disease is elusive. Therefore, our objective was to examine the effects of fluvastatin and fluvastatin plus ezetimibe on lipoprotein subfractions in patients with diabetes mellitus and/or coronary heart disease.

Interventions

DRUGfluvastatin

80 mg MR, 12 weeks

DRUGFluvastatin plus ezetimibe

fluvastatin 80 mg MR plus ezetimibe 10 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients with CHD or CHD equivalent with LDL 100-160 mg/dl * Male or female sex * Normal values of CK, AST and ALT * Normal kidney function

Exclusion criteria

* CHD Stage III-IV * St. p. myocardial infarction or coronary artery bypass grafting * Pregnancy or breastfeeding * Premenopausal women without certain contraception * Known hypersensitivity to HMG-CoA reductase inhibitors or ezetimib

Design outcomes

Primary

Measure	Time frame
Reduction in Low density lipoprotein cholesterol (LDL-C)	week 6 and 12

Secondary

Measure	Time frame
Total cholesterol, triglycerides, HDL-C, lipoprotein subfractions, hs-CRP	week 6 and 12
adverse events, CK elevation, liver enzyme elevation	week 6, 12

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026